GAO supplements report generates mixed response

By Lorraine Heller

- Last updated on GMT

Related tags Adverse events Dietary supplement

Consumer activists claim a GAO report on the oversight of dietary supplements confirms that regulatory loopholes plague the industry, while trade bodies say the report makes unrealistic recommendations to improve regulation of the products.

The new report from the Governement Accountability Office (GAO), released this week, found that the US Food and Drug Administration (FDA) is lacking in its regulation of supplements, which means consumers may be exposed to unnecessary health risks.

GAO recommended a number of changes that would be necessary to ensure a safe supplements market. These include requiring supplement manufacturers to submit lists of all products they sell and to report all adverse events related to their products – not just serious adverse events.

To access the full report, click here​ .

To read a summary of the report and recommendations from, click here​.

‘Hazardous’ supplements

According to the consumer group Center for Science in the Public Interest (CSPI), the report demonstrates that FDA “does not have even the most basic information to protect the public from hazardous supplements”.

It claims this lack of oversight and comprehensive regulations has generated a market with inconsistent product labeling and warnings, as well as the availability of some ingredients – such as kava, lobelia and aristolochic acid – that are banned in other countries.

“The supplement industry operates in a gray area where the loopholes loom larger than the law. Congress should close those loopholes by requiring that ingredients be reviewed for safety and effectiveness and that cautionary information appear on product labels,”​ said CSPI legal affairs director Bruce Silverglade.

No regulations or no resources?

Supplement trade organizations, on the other hand, said the report demonstrates that industry has made significant developments over the past decade, following the publication of GAO’s original supplements report in 2000.

Two of the largest groups – the Council for Responsible Nutrition (CRN) and Natural Products Association (NPA) – said the report highlights new regulations governing the industry, but acknowledges that FDA is under resourced.

According to CRN, this is what had allowed a small number of irresponsible firms to damage the reputation of the industry as a whole.

“Regulations are only as strong as enforcement, and it is time for FDA to focus its energy and resources on inspections and enforcement actions directed at the small minority of companies that are giving those in the majority a black eye,” ​said Steve Mister, CRN president and CEO.

How adverse are adverse events?

The primary objection expressed by the dietary supplements industry was that GAO’s recommendation that all adverse events should be reported was unrealistic and burdensome.

Currently, supplements manufacturers are required to report to FDA all serious adverse events reports that they receive. Serious adverse events are defined as those that lead to death or hospitalization.

GAO recommended that all adverse events should be reported.

“If the FDA’s resources are already stretched, as the report indicates, then adding to this burden by mandating that any complaint be dealt with by the agency does not make sense,”​ said NPA executive director and CEO David Seckman.

CRN expressed the same concerns: “The Agency is already overburdened and understaffed, and we are opposed to creating more bureaucratic paperwork that would not result in true benefits for consumer safety,”​ it said.

“The adverse event reporting law was carefully considered and supported by numerous stakeholders, including consumer groups, and there is no need to revise a law that only recently went into effect and appears to be working.”

Both CRN and NPA were interviewed by GAO for its report.

Related topics Regulation GMPs, QA & QC

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